NCT04513301

Efficacy and Safety of Sintilimab With or Without Radiotherapy in Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized,Open Labled, Phase II Clinical Study

Efficacy and Safety of Sintilimab With or Without Radiotherapy in Chinse Patients With Recurrent or IV NSCLC (EGFR -, ALK -) After Failure of Platinum-based Chemotherapy: A Randomized, Controlled, Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shanghai Cancer Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer incidence and mortality have been increasing steeply in the past thirty years in the mainland of China. More than 80% of lung cancer is non-small cell lung cancer (NSCLC). More than 40% of NSCLC patients are found to be in stage IIIb or IV, which is not resectable. The 5-year survival rate for this group of patients is less than 5% in the SEER database. Currently, the NCCN guidelines recommend platinum-containing double-drug chemotherapy as the first- line standard of care for advanced NSCLC without driver gene mutations, and treatment options after failure of first-line chemotherapy are limited. Immune Checkpoint Inhibitors, ICIs provide new treatment options, and in addition, radiotherapy can also be used in selected patients with advanced NSCLC, especially in patients with oligo progression, where irradiation of the thoracic primary lesions can improve the patient's respiratory-related symptoms, reduce the tumor burden, improve the patient's quality of life, and prolong survival in some patients. Therefore, we propose that combination of immunotherapy and radiotherapy to the primary lesion for these patients, who are generally in good KPS status, may result in improved quality of life and prolonged survival. To date, there have been no clinical studies of immunotherapy combined with primary lesions radiation therapy in patients with advanced non-small cell lung cancer (driver gene-negative) after chemotherapy failure or recurrence, so we designed this prospective, randomized, controlled, investigator-initiated, phase II clinical study with the primary objective of evaluating the efficacy of combined immunotherapy and primary lesions radiation therapy in this patient population. This trial aims at investigating the feasibility and efficacy of this treatment strategy.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab (200 mg q3w ×2 cycle)
RADIATION	Radiotherapy	RT 50-60Gy/25-30f

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2020-08-14
• Last updated: 2020-08-14

Locations

1 site across 1 country: China